trial to evaluate the safety, tolerability, and immunogenicity of a multivalent group b streptococcus vaccine when administered concomitantly with tdap in healthy nonpregnant women

Conditions: Group B Streptococcus Infections

Summary: this phase 2b, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group b streptococcus vaccine administered concomitantly with tdap in healthy nonpregnant women 18 through 49 years of age.


Eligibility criteria:
inclusion criteria: * healthy women ≥18 and ≤49 years of age. * participants who are willing and able to comply with scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures, including completion of the e-diary from day 1 to day 7 following administration of investigational product. * healthy females at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. * expected to be available for the duration of the study and who can be contacted by telephone during study participation. * capable of giving personal signed informed consent. exclusion criteria: * pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (wocbp) at visit 1 (prior to vaccination) * history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or crm197-containing vaccine. * history of microbiologically proven invasive disease caused by group b streptococcus. * immunocompromised participants with known or suspected immunodeficiency. * bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection. * other acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * previous vaccination with any licensed or investigational gbs vaccine, or planned receipt during the participant's participation in the study (through the 1-month follow-up visit \[visit 2\]). * vaccination within 5 years with tetanus and diphtheria toxoids and acellular pertussis-containing vaccines (tdap) before investigational product administration. * participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids * vaccination with diphtheria- or crm197-containing vaccine(s) from 6 months before investigational product administration, or planned receipt through the 1-month follow-up visit. * receipt or planned receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration through the 1-month follow-up visit * participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation